EAU 2021: Preliminary Results from the PEDAL Trial: A Prospective Single Arm Paired Comparison of Ability to Diagnose and Locate Prostate Cancer Between Multiparametric MRI and 18F-PSMA-PET/CT

(UroToday.com) In this study, the authors aimed to investigate the accuracy of 18F-DCFPyl-PSMA-PET/CT to detect and localize prostate lesions compared to multiparametric MRI (mpMRI) in men with suspected prostate cancer.


The study design was a prospective single-arm paired comparison trial of the ability to diagnose prostate cancer between mpMRI and 18F-DCFPyL-PSMA PET/CT. Detection and localization of suspicious prostate lesions were compared between mpMRI, PET/CT, and fused PET/MR images. Some patients underwent targeted prostate biopsy and radiological findings were correlated with histological findings.

Jumping to the results, the study included 54 men who completed both imaging arms. The median age was 66 years and median prostate-specific antigen (PSA) level 6.15ng/ml.

Prostate mpMRI detected 35 lesions (PIRADS ≥3), compared to 40 lesions on PET/CT (SUVmax ≥7.0). Twenty-five lesions were detected on both mpMRI and PET/CT, with 15 lesions identified by PET/CT alone.

When histology was assessed, prostate cancer was detected in 25 of 34 men who underwent prostate biopsy. On a per-lesion analysis, 17 of 25 (73.8%) lesions with clinically significant prostate cancer (Grade group ≥2) were visualized on both imaging arms. All clinically significant lesions identified by mpMRI were visualized on PET/CT. PET/CT identified 3 (13%) further clinically significant lesions that were undetected by mpMRI and diagnosed 11 patients with metastatic disease.

Based on this, the authors conclude 18F-DCFPyl PSMA-PET/CT is able to detect prostate lesions seen on mpMRI prostate, as well as identify additional clinically significant lesions. The ability of PSMA-PET/CT to diagnose metastatic disease also saves the need for further staging following diagnosis. These early results provide promising evidence for a fully-powered trial to follow.

Presented By: Viet Tran MBBS, FACEM, Melbourne, Australia

Written By: Thenappan (Thenu) Chandrasekar, MD – Urologic Oncologist, Assistant Professor of Urology, Sidney Kimmel Cancer Center, Thomas Jefferson University, @tchandra_uromd on Twitter during the 2021 European Association of Urology, EAU 2021- Virtual Meeting, July 8-12, 2021.

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